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New nonhormonal menopause drugs ease symptoms but face insurance hurdles

by Universalwellnesssystems

New drugs are finally on the market or in development to treat a debilitating menopausal symptom: hot flashes. But doctors say insurance companies either won’t pay for women or force them to try and fail on other, possibly less effective, drugs before they receive treatment.

This challenge leaves women who could benefit from new drugs at the mercy of health insurance companies.

“A doctor doesn’t write a prescription and go to a pharmacy to pick it up,” says Alina Salganikov, senior vice president and director of women’s health policy at KFF, a nonprofit health policy research institute. organization. “New drugs tend to cost a lot of money, and insurance plans are very reluctant to cover them.”

What are the new menopause drugs?

Hormone replacement therapy is often recommended during menopause, but some women, such as those with breast cancer, cannot receive hormone replacement therapy because the added hormones can promote cancer.

But the new drug has nothing to do with hormones.

On Thursday, Bayer said its non-hormonal drug erinzanetant “significantly” reduced the number and severity of hot flashes (intense bursts of body heat that can occur at any time of the day or night) in women in clinical trials. Announced. Erinzanetant works by targeting two receptors in the brain. One is called NK-3 and regulates body temperature. Her NK-1 also affects mood and sleep.

Astellas Pharma’s VEOZAH, fesolinetant tablets.Astellas Pharma

In fact, participants said they slept better while taking the pill in the trial.

Dr. Joanne Pinkerton, professor of obstetrics and gynecology and director of the Center for Midlife Medicine at the University of Virginia School of Medicine, led one of the erinzanetant trials.

“We haven’t seen the complete data, but it was very effective in reducing the frequency and severity of hot flashes,” she said. My sleep has improved and my overall quality of life has improved. ”

Bayer said it plans to submit the data to the Food and Drug Administration this year. If approved, it would be the second non-hormonal treatment for hot flashes.

Last year, the FDA gave the green light to Astellas Pharma’s fesolinetan, sold as Veozah. It targets NK-3, a receptor that controls body temperature. ongoing research I recently found out that it can reduce hot flashes for about 6 months.

“Moment” of menopause

Celebrities are starting to talk publicly about the once-taboo condition, which affects around half of the population.

For example, earlier this month, actor Halle Berry exclaimed, “I’m menopausal!”At a media event held at Parliament House in support of the parliamentary announcement. Bill to strengthen menopause care.

“Menopause is going through a phase,” said Dr. Rajita Patil, director of the Comprehensive Menopause Care Program at UCLA Health in California. “But it really should have happened a long time ago. It’s not like menopause is a new diagnosis.”

Still, some insurance companies are reluctant to pay for new menopause treatments. For example, Kaiser Permanente requires women to try at least two other drugs that are not FDA-approved before switching to Veozah (fesolinetant) for hot flashes, and requires women to try at least two other drugs that are not FDA-approved, with at least one month’s supply. It may cost $550. These drugs may include off-label use of the painkiller gabapentin and the antidepressant sold as Effexor.

“Women are specifically urged to try medications that are not FDA-approved to treat hot flashes before actually using FDA-approved medications to treat hot flashes,” says Stephanie, Medical Director of North American Medical Center.・Dr. Fabion said. She is director of the Menopause Society and the Mayo Clinic Women’s Health Center. “It’s frustrating.”

“I think most health care providers have difficulty with their ability to determine what is the best medicine for their patients,” Pinkerton said.

Bayer will not disclose the price of elinzanetant until it is approved by the FDA. Analysts suggest it could cost as much or more than Veozah.

“A person who changes your life”

About six years ago, Cindy Rollery, a 60-year-old pediatric organ transplant nurse at the University of Virginia School of Medicine, began suffering from hot flashes and trouble sleeping (characteristic signs of menopause).

“I was bright red and sweating profusely,” Lafley said. “People stopped me and asked if I was OK.”

Cindy Rollery says she was experiencing up to 15 hot flashes a day before taking an experimental drug that affects how the brain regulates mood and body temperature.Provided by: Cindy Lafley

She said she felt sudden bursts of fever at least 10 to 15 times a day. It took hours for her to fall asleep at night. She enrolled in Bayer’s elinzanetant trial.

It was “life-changing,” Loughley said. Her hot flashes are almost gone. When they did occur, they were much milder.

“It was a revelation,” she said. She said, “All of a sudden she felt, ‘Wow, I can get up and feel so good.'”

Lafley said he did not experience any negative side effects, but Pinkerton said the drug caused fatigue, headaches and muscle pain in some study participants.

What happens if your insurance company doesn’t cover your medication?

KFF’s Salganikov offers the following tips:

  • Visit your insurance company’s website and search for your medication. This site should tell you the exact steps you need to take to get drug coverage.
  • Contact your doctor’s office. Physicians often receive coupons or have inside knowledge about drug discounts. They also serve as patient advocates.
  • Flex patient rights and challenge insurance denials. “Just because the first answer is ‘no’ doesn’t mean it’s the final answer,” Salganikov says. “This is where persistence pays off.”

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